Principal Statistical Programmer Consultant
ClinChoice
Principal Statistical Programmer Consultant – Oncology
ClinChoice
contract
Posted on:
Origin: • 🇬🇧 United Kingdom
Visit company websiteJob Level
Lead
About the role
- Support Programming deliveries of a clinical study or project
- Implement statistical programming aspects of the protocol and the clinical development program
- Ensure high quality is built into own deliverables and those of other programmers
- Program independently with high efficiency and quality
- Write and/or implement specifications and oversee completeness of relevant documentation
- Contribute to development of best practices to improve quality, efficiency, and effectiveness
- Ensure compliance with standards and automation usage
- Plan and support team activities and tasks
- Communicate and escalate risks within assigned studies and/or projects
- Work proactively with study team members including Statistician, Lead Programmer, Data Manager and Study Leader
- Act as a client-facing consultant establishing a high-trust environment with client counterparts
Requirements
- Bachelor’s degree in computer science, statistics, or related scientific discipline with 5 years clinical programming (CDISC) experience
- Master’s degree in CS, statistics or related disciplines with 6 years clinical programming (CDISC) experience
- Oncology therapeutic area (TA) experience
- Working knowledge of ICH and Good Clinical Practices (GCP)
- Knowledge of clinical research, clinical trial process, and related regulatory requirements and terminology
- Good understanding of the clinical drug development process
- Strong communication and coordination skills
- Current knowledge of technical and regulatory requirements relevant for the role
- Ability to proactively manage concurrent activities within a project
- Proficient ability to influence relevant stakeholders on programming-related items
- Ability to work independently and in a client-facing capacity
